Request for Information (RFI): Acquisition, Processing, Preservation, and Distribution of Human Tissues to Advance Understanding and Treatment of Developmental Disabilities

Notice Number: NOT-HD-09-005

Key Dates
Release Date:  November 12, 2008
Response Date:  December 31, 2008

Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov)

Purpose

The NICHD Brain and Tissue Bank (the Bank) contributes to the advancement of research in a wide range of developmental disabilities.    To facilitate collaborative research and enhance the ability of the Bank to serve a diverse set of constituents, NICHD is exploring potential opportunities to extend and enhance the work of the bank, through collaborations and partnerships with other organizations and/or groups. The NICHD also anticipates working with other similar human tissue repositories to develop common protocols for activities in the collection, processing, storage, and distribution of brain and other tissues for research purposes.   This Request for Information (RFI) serves to notify the community that a Request for Proposals (RFP) for the Bank will be published and to provide all interested parties an opportunity to comment.

Background

In early 2009, the NICHD expects to issue a RFP for a competition to maintain an already established Brain and Tissue Bank for Developmental Disorders.  The NICHD Brain and Tissue Bank was established 18 years ago to advance research in developmental disabilities.  The objective of this Bank is to systematically collect, store, catalog, preserve, and distribute brain and other human tissues to qualified scientific investigators who are dedicated to the improved understanding, care, and treatment of individuals with developmental disabilities.  The tissue collection includes samples of normal individuals and individuals with developmental disabilities including, but not limited to, autism, Fragile X, muscular dystrophy, and Down syndrome.   

For the newly competed contract, the NICHD plans to require the establishment of a panel of scientific advisors including NICHD Program staff to review applications from investigators requesting access to tissues, particularly those that are difficult to obtain or in high demand.  For approved applications with tissue-processing requirements beyond the Bank’s standard protocol, the Bank will be expected to prepare the tissues in accordance with the requirements of the application via a cost-recovery mechanism. 

The goal of NICHD in maintaining the Bank continues to be the advancement of research in a wide range of developmental disabilities.  This research has become more complex and ripe for novel, sophisticated techniques and approaches.  To facilitate collaborative research and enhance the ability of the Bank to serve a diverse set of constituents, NICHD is exploring potential opportunities to extend and enhance the work of the bank, including collaborations and partnerships with other organizations and/or groups. The NICHD also anticipates working with other similar human tissue repositories to develop common protocols for activities in the collection, processing, storage, and distribution of brain and other tissues for research purposes.   This RFI serves to notify the community that an RFP for the Bank will be published and to provide all interested parties an opportunity to comment.
 
Information Requested

The Institute invites public input in two areas; you may respond to either one or both topics:

I.  The NICHD is seeking information from individuals, groups, and organizations who wish to comment on the activities of the current Bank.

NICHD invites interested parties to submit the following information:

II.  The NICHD is seeking information on possible enhancements of the Bank’s activities.

Interested parties may wish to comment on mechanisms for extending and enhancing the Bank’s roles or supporting the Bank’s ability to leverage its resources.  For example, some organizations may have unique expertise that can supplement that available to the Bank, such as recruitment, clinical phenotyping, and advisory functions.  Other organizations may have resources that could facilitate the data collection and tissue genotyping capabilities of the Bank. 

For information on NIH efforts to promote collaboration with a wide range of organizations to improve public health through biomedical research, please see the guidelines established by the NIH Program on Public-Private Partnerships (http://ppp.od.nih.gov).  The document outlining “NIH Principles for Extramural Agreements for Non-Federal Support” is available upon request.  The NICHD is not specifying the nature of possible involvement or support, and encourages creative suggestions. 

NICHD invites interested parties to submit the following information:

How to Submit a Response

Responses will be accepted until December 31, 2008 via email to Dr. Alice Kau at kaua@mail.nih.gov.  Please identify your message with the number of this Notice NOT-HD-09-005 in the subject line.  You will receive an email confirmation acknowledging receipt of your response.  The submitted information will be reviewed by the NICHD. Submitted information will not be considered confidential.

Inquiries

Inquiries regarding this notice may be directed to:

Alice Kau, Ph.D.
Mental Retardation and Developmental Disabilities Branch
The Eunice Kennedy Shriver National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 496-1383
Fax:  (301) 496-3791
Email:  kaua@mail.nih.gov

No basis for claims against the NIH shall arise as a result of a response to this RFI or from the NIH’s use of such information.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government.  The government will not pay for the preparation of any information submitted or for the government’s use of that information.


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